When it comes to protecting against hepatitis B, not all vaccines are created equal—and neither are the manufacturers behind them. With so many factories operating across the USA, how do you know which one truly delivers safety, quality, and reliability? Finding the right supplier can be the difference between peace of mind and unnecessary risk, especially for healthcare providers, clinics, or distributors. Ready to discover the top hepatitis B vaccine manufacturers in the USA?

Let’s dive in and make your decision easy!

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U.S. Vaccine Names | Vaccines & Immunizations | CDC

Product Details:
Vaccines licensed for use in the United States, including information for healthcare professionals about available vaccines, schedules, and clinical guidance.

Technical Parameters:
– Vaccines are licensed and approved by the FDA for safety and efficacy.
– Products include both pediatric and adult vaccines covering multiple diseases

Application Scenarios:
– Routine immunization of children and adults in clinical settings.
– Prevention of infectious diseases in community and public health programs.
– Vaccination in outbreak or high-risk situations (e.g., travel, occupational

Pros:
– Comprehensive coverage of vaccine-preventable diseases.
– Products are reviewed and monitored for safety and effectiveness by regulatory
– Guidance provided supports optimal vaccine administration and scheduling.

Cons:
– Some individuals may experience side effects or adverse reactions to vaccines.
– Not all vaccines may be suitable for every patient due to medical

Vaccine Manufacturers | Immunize.org

Product Details:
A wide range of vaccines covering diseases such as adenovirus, anthrax, BCG, chikungunya, cholera, COVID-19, dengue, diphtheria, Ebola, hepatitis A/B, Hib, HPV, influenza, Japanese encephalitis, measles, meningococcal ACWY/B, mpox, mumps, pertussis, pneumococcal, polio, rabies, rotavirus, RSV, rubella, smallpox, TBE, tetanus, typhoid, varicella, yellow fever, and zoster. Also provides Vaccine Information Statements (VISs) and resources to support vaccine administration and education.

Application Scenarios:
– Routine immunization for children and adults
– Travel-related vaccinations
– Outbreak response and epidemic control
– Healthcare professional education and patient informational support

Pros:
– Comprehensive coverage of a broad range of infectious diseases through vaccines
– Access to official Vaccine Information Statements (VISs) and translated
– Resources designed to support clinical practice and patient education
– Alignment with CDC recommended schedules and guidelines

Cons:
– No specific technical specifications or proprietary advantages listed on the
– Limited direct product feature comparison or unique selling points provided

Hepatitis B Vaccine (Recombinant) | FDA

Product Details:
The product is a recombinant hepatitis B vaccine (Hepatitis B Vaccine, Recombinant) designed to prevent hepatitis B virus infection. It is approved for use in both children and adults.

Technical Parameters:
– Contains purified surface antigen of the hepatitis B virus produced via
– Available in single-dose and multi-dose vials with varying antigen content for
– Administered intramuscularly, with a standard dosing schedule of 3 injections
– Does not contain preservatives or adjuvants; formulated without thimerosal.

Application Scenarios:
– Routine immunization of infants, children, and adolescents against hepatitis B.
– Vaccination of adults at increased risk for hepatitis B infection, such as
– Post-exposure prophylaxis in individuals exposed to hepatitis B virus.

Pros:
– Provides effective long-term protection against hepatitis B infection.
– Proven safety profile with low rates of serious adverse events.
– Does not contain live virus, suitable for immunocompromised individuals.

Cons:
– Requires multiple doses over several months to complete vaccination.
– Potential for mild side effects such as soreness at the injection site or mild

HEPLISAV-B | Dynavax Technologies

Product Details:
HEPLISAV-B is a recombinant, adjuvanted hepatitis B vaccine indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. It is approved by the FDA and EC, and distributed worldwide, with Bavarian Nordic marketing in Germany.

Technical Parameters:
– Type: Hepatitis B Vaccine (Recombinant), Adjuvanted
– Indication: Prevention of hepatitis B virus infection in adults (18+)
– Common adverse reactions: injection site pain (23%-39%), fatigue (11%-17%),
– Not to be administered to individuals with severe allergic reaction history to

Application Scenarios:
– Routine immunization of adults ages 18 and older against hepatitis B
– Universal hepatitis B vaccination in adults aged 19-59 years as recommended by
– Vaccination of adults over 60 years with risk factors or those who choose to be

Pros:
– Prevents all known subtypes of hepatitis B virus in adults
– Recommended by CDC ACIP for universal adult hepatitis B vaccination (ages 19-59
– Up to 100 times more infectious than HIV, so vaccination provides critical
– FDA and EC approved with global commercial rights

Cons:
– Should not be used for individuals with history of severe allergic reaction to
– Immunocompromised persons may have a reduced immune response
– May not prevent infection in individuals already infected at the time of
– Not indicated for use in children or adolescents under 18 years of age

HEPLISAV-B® (Recombinant), Adjuvanted – Hepatitis B Vaccine

Product Details:
HEPLISAV-B is a vaccine indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Technical Parameters:
– Recombinant, adjuvanted hepatitis B vaccine
– Administered as a 2-dose series, one month apart
– Each dose contains 20 mcg HBsAg and 3,000 mcg CpG 1018 adjuvant

Application Scenarios:
– Immunization of adults 18 years of age and older against hepatitis B
– Use in healthcare settings requiring rapid and reliable hepatitis B protection

Pros:
– Only 2 doses needed for full protection, spaced 1 month apart
– Demonstrated higher seroprotection rates compared to conventional 3-dose
– May improve compliance due to shortened dosing schedule

Cons:
– Not indicated for use in individuals younger than 18 years
– Safety and efficacy not established in populations such as hemodialysis patients

Everything You Need To Know About The Hepatitis B Vaccine

Product Details:
The website provides FDA-approved package inserts for Hepatitis B vaccines, offering detailed information about various Hepatitis B vaccine brands and formulations.

Technical Parameters:
– Includes package inserts for different Hepatitis B vaccines such as Engerix-B,
– Covers information on vaccine composition, dosage forms (e.g., single-dose
– Presents data on vaccine components, efficacy, safety, and storage requirements.
– Contains official prescribing information from manufacturers.

Application Scenarios:
– Healthcare professionals seeking official vaccine information for reference or
– Pharmacists, nurses, and physicians administering Hepatitis B vaccinations.
– Patients or caregivers looking for detailed vaccine documentation.

Pros:
– Centralized access to official, up-to-date Hepatitis B vaccine insert documents.
– Easy comparison of multiple vaccine brands and formulations.
– Useful for compliance, education, and informed consent processes.

Cons:
– Does not offer actual vaccines, only informational inserts.
– Website may require users to interpret complex medical terminology.
– Absence of direct product support or medical advice.

Recombivax HB® Hepatitis B Virus Vaccine – McKesson

Product Details:
Recombivax HB® Hepatitis B Virus Vaccine (Recombinant), Preservative Free, 5 mcg/0.5 mL Injection. Distributed by McKesson, product by Merck.

Technical Parameters:
– Preservative Free formulation
– 5 micrograms Hepatitis B surface antigen per 0.5 mL dose
– Injection volume: 0.5 mL
– Recombinant vaccine

Application Scenarios:
– Routine immunization against Hepatitis B in healthcare settings
– Immunization of newborns, children, and adults at risk for Hepatitis B infection
– Hospital, clinic, and physician office vaccine programs

Pros:
– Preservative free, reducing potential for allergic reactions to preservatives
– Recombinant technology offers a high level of safety and purity
– Suitable for a wide range of patient groups including infants and adults

Cons:
– Requires injection, which may be less preferred by needle-averse patients
– Cold-chain storage needed, impacting transport and handling logistics

VBI Vaccines Announces PreHevbrio™ is Now Available in the United …

Product Details:
PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] is the only approved 3-antigen hepatitis B vaccine for adults in the U.S., indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

Technical Parameters:
– Contains three hepatitis B antigens: S, Pre-S1, Pre-S2
– FDA approved as of November 30, 2021
– Unique CPT code established for 3-antigen (S, Pre-S1, Pre-S2) vaccine
– Wholesale Acquisition Cost (WAC) of $64.75 per dose

Application Scenarios:
– Routine preventive vaccination of adults aged 18 years and older against
– Universal HBV vaccination recommendation for all adults age 19-59 based on ACIP
– Vaccination campaigns led by healthcare providers, following CDC and ACIP

Pros:
– Only 3-antigen HBV vaccine approved for use in adults in the U.S., potentially
– Covers all known subtypes of hepatitis B virus
– Added to ACIP’s list of recommended adult hepatitis B vaccines, supporting

Cons:
– Should not be used in individuals with a history of severe allergic reaction to
– Immunocompromised persons may have a diminished immune response
– Side effects such as pain, tenderness at injection site, myalgia, fatigue, and

Dynavax Announces FDA Approval of HEPLISAV-B™ for Prevention of …

Product Details:
Heplisav-B is a hepatitis B vaccine developed by Dynavax for the prevention of infection caused by all known subtypes of hepatitis B virus in adults.

Technical Parameters:
– Administered as a two-dose series given one month apart
– Indicated for adults aged 18 years and older
– Contains a novel adjuvant (CpG 1018) designed to improve immune response

Application Scenarios:
– Immunization of adults against hepatitis B infection
– Suitable for adults at increased risk of hepatitis B exposure (e.g., healthcare

Pros:
– Shorter vaccine schedule compared to traditional three-dose hepatitis B vaccines
– Demonstrated higher rates of protection in clinical studies for specific
– Well tolerated with a safety profile similar to other licensed hepatitis B

Cons:
– Approved only for adults (18 years and older), not indicated for children
– Limited long-term post-market safety data compared to older vaccines

Hepatitis B Vaccine Administration | Hepatitis B | CDC

Product Details:
Hepatitis B vaccines and vaccination administration services for healthcare professionals.

Technical Parameters:
– Vaccines are administered intramuscularly, typically in the deltoid muscle for
– Standard dosage schedules: usually a 3-dose series (0, 1, and 6 months), with
– Single-antigen vaccines and combination vaccines available.

Application Scenarios:
– Routine childhood immunization programs.
– Vaccination of adults at risk for Hepatitis B infection (such as healthcare

Pros:
– Highly effective in preventing Hepatitis B infection when the full vaccine
– Can be administered alongside other routine immunizations without interference.

Cons:
– Requires multiple doses over several months for full immunity.
– Some individuals may experience mild side effects such as soreness at the

Comparison Table

Company	Product Details	Pros	Cons	Website
U.S. Vaccine Names	Vaccines & Immunizations	CDC	Vaccines licensed for use in the United States, including information for	Comprehensive coverage of vaccine-preventable diseases. Products are reviewed
Vaccine Manufacturers	Immunize.org	A wide range of vaccines covering diseases such as adenovirus, anthrax, BCG,	Comprehensive coverage of a broad range of infectious diseases through	No specific technical specifications or proprietary advantages listed on the
Hepatitis B Vaccine (Recombinant)	FDA	The product is a recombinant hepatitis B vaccine (Hepatitis B Vaccine,	Provides effective long-term protection against hepatitis B infection. Proven	Requires multiple doses over several months to complete vaccination. Potential
HEPLISAV-B	Dynavax Technologies	HEPLISAV-B is a recombinant, adjuvanted hepatitis B vaccine indicated for the	Prevents all known subtypes of hepatitis B virus in adults Recommended by CDC	Should not be used for individuals with history of severe allergic reaction to
HEPLISAV-B® (Recombinant), Adjuvanted – Hepatitis B Vaccine	HEPLISAV-B is a vaccine indicated for prevention of infection caused by all	Only 2 doses needed for full protection, spaced 1 month apart Demonstrated	Not indicated for use in individuals younger than 18 years Safety and efficacy	www.heplisavbhcp.com
Everything You Need To Know About The Hepatitis B Vaccine	The website provides FDA-approved package inserts for Hepatitis B vaccines,	Centralized access to official, up-to-date Hepatitis B vaccine insert documents	Does not offer actual vaccines, only informational inserts. Website may require	justtheinserts.com
Recombivax HB® Hepatitis B Virus Vaccine – McKesson	Recombivax HB® Hepatitis B Virus Vaccine (Recombinant), Preservative Free, 5	Preservative free, reducing potential for allergic reactions to preservatives Re	Requires injection, which may be less preferred by needle-averse patients Cold-c	mms.mckesson.com
VBI Vaccines Announces PreHevbrio™ is Now Available in the United …	PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] is the only approved 3-antigen	Only 3-antigen HBV vaccine approved for use in adults in the U.S., potentially	Should not be used in individuals with a history of severe allergic reaction to	www.vbivaccines.com
Dynavax Announces FDA Approval of HEPLISAV-B™ for Prevention of …	Heplisav-B is a hepatitis B vaccine developed by Dynavax for the prevention of	Shorter vaccine schedule compared to traditional three-dose hepatitis B	Approved only for adults (18 years and older), not indicated for children Limite	www.naccho.org
Hepatitis B Vaccine Administration	Hepatitis B	CDC	Hepatitis B vaccines and vaccination administration services for healthcare	Highly effective in preventing Hepatitis B infection when the full vaccine

Frequently Asked Questions (FAQs)

How can I find reputable hepatitis B vaccine manufacturers in the USA?
Start by searching official FDA databases and industry directories, such as the FDA’s Approved Drug Products list. You can also attend pharmaceutical trade shows and network with industry professionals for recommendations. Always double-check each manufacturer’s licensing and certification status to ensure reliability.

What certifications should a trustworthy hepatitis B vaccine manufacturer have?
Reliable manufacturers should be FDA-approved and comply with Good Manufacturing Practice (GMP) standards. Look for additional third-party quality certifications like ISO 13485, which indicates adherence to international standards for medical devices and pharmaceuticals.

How do I evaluate the quality of a vaccine supplier’s products?
Request documentation like certificates of analysis, batch testing results, and details on their quality control processes. You can also review client testimonials and inquire about the supplier’s track record with regulatory inspections and recalls.

What factors should I consider when choosing a hepatitis B vaccine supplier?
Consider their product portfolio, manufacturing capacity, history of supply reliability, and ability to meet your specific needs, including packaging and shipping requirements. Customer service responsiveness and flexibility in contract terms are also important.

Can hepatitis B vaccine manufacturers in the USA accommodate bulk and custom orders?
Many large manufacturers can handle bulk or custom orders; however, minimum order quantities may apply. Discuss your specific requirements directly with the supplier to confirm their ability to meet your demand and any customization needed for your market.